Fecal transplants hold promise, but face regulatory hurdles

One of the most refreshing things about science is that it doesn't care whether it offends you. It presents the data, and whether you take it or leave it is your business. Science doesn't care.

Take, for example, fecal transplants.

Yes, it is what it sounds like -- taking a healthy person's stool and transplanting it into a patient's large intestine.

If you're already turning up your nose at the idea, ready to click to a more civilized section of the Internet, you are not alone. Doctors, scientists and whole hospital staffs can't get over the ick factor, causing them and their patients to miss out on one of the most promising cures for a growing problem.

If you think fecal transplants are old news (because, well, they are old, if not widely known, news), then you should know that they are on our radar again because Scientific American is publishing in its December 2011 issue an essay, "Swapping Germs," by science journalist Maryn McKenna describing the health benefits of fecal transplants and the regulatory hurdles the treatment faces.

How it works

What a fecal transplant seems to do is allow the bacteria from the healthy stool to repopulate the gut of the patient who has lost healthy bacteria in their gut or who has a preponderance of bad bacteria there.

And it's an especially enticing procedure because of a really nasty bacteria called Clostridium difficile that grows in people's intestines and causes health problems ranging from persistent diarrhea to life-threatening inflammation of the colon to death.

One University of Minnesota doctor, Alex Khorutus, who has performed two dozen fecal transplants explains what led him to conclude that the bacteria from the healthy stool was repopulating the intestines of the patients. McKenna writes:

In 2010 he analyzed the genetic makeup of the gut flora of a 61-year-old woman so disabled by recurrent C. diff that she was wearing diapers and was confined to a wheelchair. His results showed that before the procedure, in which the woman received a fecal sample from her husband, she harbored none of the bacteria whose presence would signal a healthy intestinal environment. After the transplant -- and her complete recovery -- the bacterial contents of her gut were not only normal but were identical to that of her husband.

What there is to like about fecal transplants

C. difficile has become more and more common in recent years as a result of antibiotic treatments. An especially virulent new strain emerged in 2000, and now the deadly bacterial infection has been seen not only in elderly patients but also in children, pregnant women and otherwise healthy people.

As McKenna writes:

One study estimated that the number of hospitalized adults with C. diff more than doubled from about 134,000 patients in 2000 to 291,000 patients in 2005. A second study showed that the overall death rate from C. diff had jumped fourfold, from 5.7 deaths per million in the general population in 1999 to 23.7 deaths per million in 2004.

The second part of the two-part punch is that C. diff is also now harder to cure. It has become more resistant to antibiotics, and so the new standard treatment is to employ two antibiotics. The only problem is that these two antibiotics kill off the friendly bacteria in the gut, too, and so any C. diff organisms that survive end up having a lot more room to repopulate.

And repopulate, they often do: One in five people who have C. diff once get it again, and 40% of that group will get it a second time, and 60% of the people that have it twice will get it a few more times. It sometimes even gets to the point where a patient has to have their colon removed.

So, when you've got something this annoying, you want a treatment that will work. And that's where the fecal transplant comes in: Medical journals show that in about 300 such transplants, more than 90% of the patients recovered completely from C. diff.

Next Steps

Before fecal transplants become a technique widely adopted by hospitals and reimbursed by insurers, the treatments needs to be studied in a randomized clinical trial of two groups: those receiving the treatment and those who are not.

But a few bureaucratic hurdles must be overcome. First, the National Institutes of Health will only study substances deemed "investigational" by the Food and Drug Administration.

And what are those substances normally? Drugs, as you would expect. Devices, yet another obvious choice. And lastly biological products such as vaccines and tissues. But feces? They don't really fit anywhere.

Aside from that, protocols need to be established. In the experiments so far, most patients have received transplants from their relatives or spouses, but if this became a widespread treatment, it might be cumbersome to deal with new "donors" for every transplant, because each one has to be screened as rigorously as a blood donor does. That could get time-consuming and costly very quickly.

One proposed solution is having a pool of "universal donors" (read: healthcare workers). Another idea is to manufacture drugstore enema kits that patients can take home to perform the transplant on themselves.

But in the meantime, many other obstacles need to be cleared, and some data needs to be gathered before this can could be turned into a widespread cure. Canada has already begun three trials, and some U.S. doctors are submitting a proposal for a trial here in the U.S.

But until doctors can put fecal transplants through the paces and get good data, don't poo-poo the idea.

via: Scientific American

photo: Un naturaliste du Midi/Wikimedia Commons

This post was originally published on Smartplanet.com